A Greek registry of current type 2 diabetes management, aiming to determine core clinical approaches, patterns and strategies.

BACKGROUND: To analyze data in terms of the glycaemic control and therapeutic regimens used for Type-2 Diabetes Mellitus (T2DM) management in Greece, identify factors that influence clinical decisions and determine the level of compliance of T2DM management with the latest international and local guidelines. METHODS: 'AGREEMENT' was a national-multicenter, non-interventional, cross-sectional disease registry. A total of 1191 adult T2DM patients were enrolled consecutively from 59 sites of the National Health System (NHS) or University Hospitals, representing the majority of Diabetes centers or Diabetes outpatient clinics in Greece with a broad geographic distribution. Patients were stratified by gender and analysis was done according to 3 treatment strategies: A (lifestyle changes or use of one oral antidiabetic agent), B (up to 3 antidiabetic agents including injectables but not insulin) and C (any regimens with insulin). RESULTS: Mean (±SD) HbA1c % of the total population was 7.1 (±1.2) while mean (±SD) FPG (mg/dl) was measured at 136 (±42). The proportion of patients who achieved HbA1c < 7% was 53% and ranged from 74.2% for group A, to 60.6% for group B and 35.5% for group C. Median age of the studied population was 65.0 year old (Interquartile Range-IQR 14.0) with an equal distribution of genders between groups. Patients on insulin therapy (treatment strategy C) were older (median age: 67 years vs 63 or 65 for A and B, respectively) with longer diabetes duration (mean duration: 15.3 years vs 5.2 and 10.1 for A and B, respectively). Patients who received insulin presented poor compliance. There was a consensus for a series of decision criteria and factors that potentially influence clinical decisions, used by physicians for selection of the therapeutic strategy among the three groups. Compliance with international and Greek guidelines received a high score among groups A, B and C. No significant differences were presented as per sites' geographic areas, NHS or University centers and physicians' specialty (endocrinologists, diabetologists and internists). CONCLUSIONS: The presented findings suggest the need for improvement of the glycaemic control rate, especially among insulin treated patients as this group seems to achieve low glycaemic control, by setting appropriate HbA1c targets along with timely and individualised intensification of treatment as well as post-therapy evaluation of the compliance with the proposed treatment.

Real-World Adequacy of Glycaemic Control in Treatment-Naïve Greek Patients with Type 2 Diabetes Mellitus Initiating Treatment with Metformin Monotherapy at the Maximum Tolerated Dose: The Reload Study.

BACKGROUND: Metformin, in the absence of contraindications or intolerance, is recommended as first-line treatment for patients with type 2 diabetes mellitus (T2DM). This observational, retrospective study assessed the real-world adequacy of glycaemic control in Greek patients with T2DM initiating metformin monotherapy at maximum tolerated dose. METHODS: Included patients received metformin monotherapy for ≥24 months; relevant patient data were collected immediately prior to metformin initiation (baseline) and at other prespecified time points. The primary objective was to report, after 9 months of metformin treatment, the percentage of patients with baseline glycated haemoglobin (HbA1c) levels ≥6.5% (≥48 mmol/mol) achieving HbA1c<6.5%. Secondary objectives included the assessment of time spent with poor glycaemic control and time to treatment intensification. A sensitivity analysis assessed the percentage of patients with baseline HbA1c≥7% (≥53 mmol/mol) achieving HbA1c<7% (<53 mmol/mol). RESULTS: Of the enrolled patients (N=316), 247 had baseline HbA1c ≥6.5%; following 9 months on metformin, 90 (36.4%) patients achieved HbA1c<6.5% (mean HbA1c change-1.3% [-14 mmol/mol]). Median time of exposure to HbA1c ≥6.5% was 23.4 months and time to treatment intensification was 28.0 months. The sensitivity analysis revealed that the proportion of patients achieving HbA1c<7.0% was 50% (mean HbA1cpy for up to 24 months. Addressing clinical inertia could improve disease outcomes and, possibly, economic burden.

Influence of Supervised Disease Understanding and Diabetes Self-Management on Adherence to Oral Glucose-Lowering Treatment in Patients with Type 2 Diabetes.

INTRODUCTION: Systematic patient education has been reported to improve adherence to treatment, leading to better clinical outcomes. This cluster randomized real-world study investigated the effect of a systematic education program and telephone support on self-reported adherence to oral glucose-lowering treatment in patients with type 2 diabetes mellitus (T2DM). METHODS: Centers were randomized (1:1) to provide either standard-of-care (control group) or standard-of-care along with the education program and telephone support (empowerment group). Adherence to treatment and satisfaction with treatment were assessed using the four-item Morisky Medication Adherence Scale (MMAS-4) and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The study population included 457 patients (258/199 male/female) with T2DM and non-optimal glycemic control, on oral antidiabetic treatment (age 62.7 [11.4]; disease duration 8.5 [6.5] years). RESULTS: MMAS-4 high adherence rates for the control and empowerment groups were increased by 3.8% and 16.8% at 4 months (Breslow-Day test p = 0.04) and by 8.5% and 18.8% at 8 months of follow-up, respectively (Breslow-Day test p = 0.09), compared to baseline. Intense physical activity was increased in both control and empowerment groups by 2.3% and 13.9% at 4 months (Breslow-Day test p = 0.082) and by 4.0% and 22.5% at 8 months of follow-up (Breslow-Day test p < 0.001). Baseline mean (SD) HbA1c was significantly lower in the control group compared with the empowerment group [7.7% versus 8.0%, p = 0.001] and decreased in both groups at 4 months by 0.7% and 0.9%, respectively. The change from baseline in the mean DTSQ status score at 4 months was greater in the empowerment group, and the effect was sustained at 8 months (control group: 29.1, 30.5, and 30.9; empowerment group: 25.0, 28.7, and 29.4 at baseline, 4 and 8 months, respectively, p < 0.001). CONCLUSION: Systematic education combined with telephone support delivered by physicians might be associated with improvement in treatment adherence and treatment satisfaction in patients with T2DM. FUNDING: MSD, Greece.

Evaluation of insulin resistance and sodium sensitivity in normotensive offspring of hypertensive individuals.

BACKGROUND: Sodium sensitivity (SS) and insulin resistance (IR) might be a common link in the pathogenesis of essential hypertension. The aim of the present study is to investigate the relationship, if any, between SS and IR in a population with a family predisposition to develop hypertension. METHODS: Twenty normotensive subjects aged 20 to 40 years with a family history of hypertension (1 or both parents hypertensive) and no other risk factor (group A) and 10 normotensive subjects aged 20 to 40 years without a family history of hypertension (group B) were enrolled. SS and IR were estimated using the euglycemic clamp technique and correlated in both groups. Blood pressure, mean blood pressure (MAP), and biochemical control were recorded. RESULTS: The frequency of SS was equal in offspring of hypertensive subjects and the control group. Individuals with a family history of hypertension had a tendency to develop IR (45%) compared with the control group (20%). This group had a greater MAP at both salt-loading and salt-deprivation periods. Increased IR was associated with increased MAP. No significant relationship was found between SS and IR in either the entire sample or the subgroup of individuals with a family history of hypertension. Serum urea and total cholesterol levels were significantly greater in group A. Age, sex, and body mass index were not related to the presence of IR or SS in either group. CONCLUSION: SS and IR do not relate in young normotensive adults or offspring of hypertensive parents. However, the latter may comprise a high-risk group, currently normotensive, who have an increased possibility to present or develop IR in early adolescent life. Moreover, the increased IR is related to the greater MAP in group A. Thus, they are subject to increased cardiovascular risk because of the subsequent disturbed glucose and lipid metabolism.

Combinations of insulin and oral hypoglycemic agents in diabetes mellitus type 2.

Insulin therapy is considered to be the most effective therapy for the reduction of high glucose levels. In patients who cannot be regulated with the combination of oral hypoglycemic agents, insulin should be administrated. The first step is the combination of insulin together with the already administrated oral hypoglycemic agents. The fear for hypoglycemia, the refusal and weakness that patients face when dealing with insulin, constitute reasons for many doctors to deal with insulin therapy in a more skeptical way. As a result, the initiation of insulin therapy is delayed for those patients who need it for hyperglycemia adjustments. This article provides useful practical instructions for initiating insulin therapy.

Clinical and biochemical manifestations of syndrome X in obese children.

UNLABELLED: The aim of this study was to investigate whether the clinical and metabolic characteristics of syndrome X had their onset in childhood in otherwise healthy but obese children of Greek origin. A group of 25 obese children and 18 age- and sex matched control subjects, aged 6-14 years, underwent an oral glucose tolerance test (OGTT), assessed for determination of plasma glucose and insulin levels. Insulin sensitivity and insulin resistance were estimated by mathematical models using calculations obtained during the OGTT. Body mass index (BMI) and blood pressure were measured, as well as serum lipoprotein and aminotransferase concentrations, after an overnight fast. The obese children had significantly higher blood pressure (systolic and diastolic) (P<0.001), triglycerides, lipoprotein(a) and alanine aminotransferase levels (P<0.05) and significantly lower HDL-cholesterol and apolipoprotein A-1 values (P<0.001). Plasma glucose levels during the OGTT were similar in both obese children and control subjects, while plasma insulin levels were significantly higher in obese children (P<0.01). In mathematical models, mean values of insulin sensitivity predictors: metabolic clearance rate and insulin sensitivity index were significantly lower in obese children (P<0.001). Predictors of beta-cell function: insulin resistance index and insulin release index were significantly higher in obese children (P<0.001). CONCLUSION: Childhood adiposity was associated with all traditional components of syndrome X. The early recognition of these factors as predisposing elements of the appearance of metabolic syndrome requires the development of strategies to manage excess weight gain during childhood, with the ultimate goal being the prevention of type 2 diabetes and cardiovascular disease in adulthood.